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Medical Devices and Drugs

Taking Action in Cases Involving Defective Medical Devices and Drugs

Many of the companies that manufacture pharmaceuticals (prescription drugs) and medical devices (bone and joint replacements, pacemakers, pain management devices, instruments used for procedures or which are implanted in patients) often consider the profit of selling the drugs and devices without fully considering the public safety and consequences inherent in some of these items. An unsafe or untested medical product can cause serious and even fatal injury. While products may have been tested before they were put in the public marketplace, in many instances the testing was improper or did not fully disclose all of the risks. At Rush & Gransee, L.C., we are experienced in investigating and pursuing medical negligence claims involving injuries from medical devices and drugs.

In a recent instance, we were contacted by a family to bring a claim against a doctor for catastrophic injuries resulting from a medical procedure that was conducted in a physician's office/clinic. Upon investigation, we determined that the injury was not caused solely by the doctor's conduct, but was most likely caused by a medical device that the doctor used in the procedure. Instead of bringing the lawsuit against the doctor alone (which would have severely limited the recovery to our client due to the limits and caps under Texas law) we were able to obtain a multimillion-dollar settlement for our client against the manufacturer of the medical device because the device and the training that the company provided to the doctor were the root cause of the traumatic injuries.

Another concern for patients, and an area that requires investigation by a medical malpractice attorney, is whether a medical device was used in a manner not approved by the Food and Drug Administration (the "FDA").

A medical doctor can use and prescribe prescription drugs and medical devices in a manner and in ways not intended or approved by the Food and Drug Administration. It is not uncommon for physicians and other health care providers to use drugs and medical devices and products in a manner not intended or approved. This is referred to "off-label" use. This nonapproved use (or off-label use) by physicians is common and can have benefits for patients; but only a physician, after exercising sound medical judgment, may make the decision for off-label use. Even so, when a doctor decides to use a drug or device in an off-label manner, the failure to exercise reasonable care in this treatment method can give rise to liability. However, a company that manufactures a drug or medical device cannot promote its use in a way not approved by the FDA — any advertisement or representation indicating off-label or nonapproved uses of drugs or devices by the manufacturer or its representatives can lead to liability for the harm caused by off-label use.

Recently, the Justice Department investigated whether Medtronic Inc. was promoting the off-label use of its product that was approved by the FDA to promote bone growth in the lumbar (low back) region. The allegations against Medtronic Inc. were that it promoted the "off-label use" of the Infuse Bone Graft product in the cervical (neck) region even though it was only approved for use in the lumbar region. The problem with using the product in the cervical region is that some patients had difficulty breathing or swallowing as a result of Medtronic's Bone Graft being used in the neck area. Therefore, if a potential client complained of difficulty breathing or swallowing following a cervical neck surgery it may be prudent to determine whether a type of manufactured bone graft was used in an off-label manner and whether the manufacturer promoted the off-label use that caused the harm.

The advantage for medical malpractice victims is that a lawsuit against a device manufacturer or drug manufacturer is not burdened by the limit on recovery against medical providers that was imposed by the Texas legislature — a limit that does not allow for full compensation of an injured person's losses. It takes an experienced and established law firm to fully investigate and understand the potential routes of recovery for compensation of serious and catastrophic injuries that may have multiple causes and complex issues to be evaluated and uncovered.

Contact us for more information.